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K Number
K992677
Device Name
EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
Manufacturer
HOLOGIC, INC.
Date Cleared
1999-09-03

(24 days)

Product Code
KGI
Regulation Number
892.1170
Type
Special
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The intended use of the Eagle software for the Hologic QDR X-Ray Bone Densitometers is estimation of BMD.
The intended use of the Hologic Eagle Software Option is to estimate the projected bone mineral density (BMD, in g/cm2) and the Bone Mineral Content (BMC, in g) at various anatomical sites using the Hologic QDR® X-Ray Bone Densitometers.

Device Description

The Eagle software operates with the Microsoft® Windows® 98 operating system and is a direct evolution from the software that is currently shipping with the QDR X-ray bone densitometers.

AI/ML Overview

The Eagle software for the Hologic® QDR® X-Ray Bone Densitometers is intended for the estimation of Bone Mineral Density (BMD) and Bone Mineral Content (BMC) at various anatomical sites. The provided text, however, does not contain specific acceptance criteria or details of a study demonstrating how the device meets them. The document is a 510(k) summary and an FDA clearance letter, which confirm the device's substantial equivalence to a predicate device but do not typically include detailed study results or acceptance criteria.

Therefore, the following information cannot be extracted from the provided text:

  1. A table of acceptance criteria and the reported device performance: This information is not present.
  2. Sample size used for the test set and the data provenance: This information is not present.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
  4. Adjudication method for the test set: This information is not present.
  5. If a multi-reader multicase (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This information is not present.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present.
  7. The type of ground truth used: This information is not present.
  8. The sample size for the training set: This information is not present.
  9. How the ground truth for the training set was established: This information is not present.

The document primarily states that the Eagle software is a direct evolution from existing software for Hologic QDR X-ray bone densitometers and is substantially equivalent to currently commercialized Hologic QDR X-Ray Bone Densitometers. The FDA clearance (K992677) confirms this substantial equivalence but does not provide the underlying performance study details.

§ 892.1170 Bone densitometer.

(a)
Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.